Phase II Clinical Study of Pegylated Liposomal Doxorubicin Hydrochloride Injection as 2nd-line or Later Therapy in Patients With Mullerian Carcinoma (Epithelial Ovarian Carcinoma, Primary Carcinoma of Fallopian Tube, Peritoneal Carcinoma) Having Pri

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to assess the effectiveness and safety of pegylated liposomal doxorubicin hydrochloride injection in Japanese patients with Mullerian carcinoma. This clinical study is a multi-center, non-randomized, open-label study in Japanese patients with Mullerian carcinoma (including epithelial ovarian carcinoma, primary carcinoma of fallopian tube, peritoneal carcinoma) with a prior history of platinum-based chemotherapy. Eighty patients will be administered intravenously at least two cycles of 50 mg/m2 of pegylated liposomal doxorubicin hydrochloride every 4 weeks to investigate the effectiveness and safety of the treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Pharmaceutical K.K.
• Treatments: Doxorubicin; Liposomal doxorubicin

Criteria

Inclusion Criteria:

• Patients with ovarian cancer who had a response to initial treatment but then relapsed within 12 months are eligible

• Patients with ovarian cancer who have received one or two prior chemotherapy treatment are eligible

• Patients must have measurable disease, good performance status and adequate major organ function

Exclusion Criteria:

• Patients with concomitant disease that may affect the conduct of the study and the evaluation of pegylated liposomal doxorubicin hydrochloride

• Patients with systemic infection

• Patients with active second cancer besides the ovarian cancer

• Patients with pleural effusion or ascites requiring continuous drainage at the time of enrollment

• Patients with pericardial fluid requiring drainage

• Patients with myocardial infarction and/or angina attack within 90 days prior to enrollment.